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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K881207
Device Name RES-Q 1, 2, 3, 4 AND 5
Applicant
NOVA-VENTRX
4309 REGENCY DR.
WHEELING,  IL  60025
Applicant Contact BERNARD R PALUCH
Correspondent
NOVA-VENTRX
4309 REGENCY DR.
WHEELING,  IL  60025
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/21/1988
Decision Date 08/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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